US20100185170A1 - Radiopharmaceutical unit dose container tamper evident safety seal - Google Patents
Radiopharmaceutical unit dose container tamper evident safety seal Download PDFInfo
- Publication number
- US20100185170A1 US20100185170A1 US12/357,017 US35701709A US2010185170A1 US 20100185170 A1 US20100185170 A1 US 20100185170A1 US 35701709 A US35701709 A US 35701709A US 2010185170 A1 US2010185170 A1 US 2010185170A1
- Authority
- US
- United States
- Prior art keywords
- seal
- connector
- band
- leg
- breakaway
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/015—Transportable or portable shielded containers for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/06—Details of, or accessories to, the containers
- G21F5/12—Closures for containers; Sealing arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
Definitions
- the present disclosure relates to a safety sealing mechanism used in conjunction with radiopharmaceutical unit dose containers.
- radioactive materials known as radiopharmaceuticals
- radiopharmaceuticals are used in various applications.
- radiopharmaceuticals are delivered to a caregiver from an outside pharmacy “pre-loaded” into a syringe. Due to the radioactive nature of such radiopharmaceuticals, great care must be utilized in handling.
- the radiopharmaceutical pig generally consists of a base and a cover that is threadably attachable to the base.
- the seal includes a first band, a second band and a connector assembly adapted to be positioned around the container.
- First and second arms connect the first band to the second band.
- the connector assembly includes a connector connecting two ends of the seal together and a breakaway portion provided to separate two ends of the seal so as to provide visual evidence the seal has been broken.
- the first band forms an uninterrupted circle adapted to be positioned around an upper portion of the container and the second band includes the connector assembly and is adapted to be positioned around a lower portion of the container.
- the first arm connects the first band to a first leg of the connector assembly and the second arm connects the first band to a second leg of the connector assembly.
- FIG. 1 is a perspective view of an assembly including a safety seal partially assembled to a radiopharmaceutical container.
- FIG. 2 is a perspective view of the safety seal of FIG. 1 .
- FIG. 1 illustrates an assembly including a harness or safety seal 10 partially assembled to a radiopharmaceutical container or pig 12 .
- the radiopharmaceutical pig 12 generally includes (upon final assembly) a tube 14 from which a flange 16 radially projects.
- the tube 14 includes upper and lower portions 18 a , 18 b , with the flange 16 consisting of threadably secured halves 16 a , 16 b that are affixed with respect to a corresponding one of the tube portions 18 a , 18 b.
- the harness 10 is formed of a flexible, strong material, such as low density polyethylene (LDPE), and defines a first band or ring 20 , arms 22 a , 22 b , and a second band or ring forming a connector assembly 24 .
- LDPE low density polyethylene
- Other types of plastic can also be used, such as polypropylene, high density polyethylene (HDPE), etc.
- the first band 20 is a continuous, uninterrupted circle (or similar shape) having a diameter greater than that of the tube 14 , but less than that of the flange 16 .
- the arms 22 a , 22 b interconnect the first band 20 with the connector assembly 24 .
- the connector assembly 24 includes opposing legs 26 a , 26 b , and a connection tab 28 .
- Leg 26 a extends between first and second ends 30 a , 32 a
- leg 26 b extends between first and second ends 30 b , 32 b .
- the connector assembly can be formed in one or more of the other portions of seal 10 .
- the connector assembly can be formed in first band 20 , arms 22 a , 22 b and/or combinations thereof.
- the first ends 30 a , 30 b are interconnected by the connection tab 28 .
- the first end 30 a is connected to a first portion of the tab 28 and spaced apart from the first end 30 b .
- the second ends 32 a , 32 b are free.
- the second ends 32 a , 32 b can be moved relative to one another, allowing a diameter collectively defined by the legs 26 a , 26 b to be increased or decreased as desired.
- the first leg 26 a forms a male plug 34
- the second leg 26 b forms a female receptacle 36 at the corresponding second end 32 .
- the plug 34 /receptacle 36 are configured such that the plug 34 can be captured within the receptacle 36 , and such that once captured, the plug 34 cannot be removed from the receptacle 36 without destroying the plug 34 (i.e., forming a non-removable connector).
- the seal 10 is applied over the radiopharmaceutical pig 12 by sliding the connector assembly 24 and the first band 20 over the tube 14 . Due to the extendable nature of the legs 26 a , 26 b relative to one another at the second ends 32 a , 32 b , the collective diameter of the legs 26 a , 26 b can be expanded so as to slide over the flange 16 .
- the first band 20 has a diameter less than that of the flange 16 , and thus cannot slide beyond the flange 16 .
- the second ends 32 a , 32 b are compressed toward one another by a user, causing the plug 34 to be inserted within, and thus by captured by, the receptacle 36 .
- two grips 38 , 40 extend from the second ends 32 a , 32 b , respectively, which can be pressed together to secure plug 34 into receptacle 36 .
- an effective diameter of the connector assembly 24 is now less than that of the flange 16 .
- the harness 10 is “locked” about the flange 16 .
- the pharmaceutical pig 12 cannot be disassembled (i.e., the flange halves 16 a , 16 b cannot be disassembled from one another).
- connection tab 28 e.g., the connection tab 28 is twisted relative to the legs 26 a , 26 b .
- first ends 30 a , 30 b can freely be moved relative to one another, allowing a user to displace the legs 26 a , 26 b to an effective diameter greater than that of the flange 16 .
- the user can now slide the seal 10 off of the pharmaceutical pig 12 .
- connection tab 28 e.g., the connection tab 28 will no longer be connected to one or both of the legs 26 a , 26 b ), whereas the second ends 32 a , 32 b will remain connected to one another.
- a visual indication that the pharmaceutical pig has been opened (or at least an attempt was made to open) will be quickly evident.
Abstract
Description
- The present disclosure relates to a safety sealing mechanism used in conjunction with radiopharmaceutical unit dose containers. In the field of nuclear medicine, radioactive materials (known as radiopharmaceuticals) are used in various applications. Typically, radiopharmaceuticals are delivered to a caregiver from an outside pharmacy “pre-loaded” into a syringe. Due to the radioactive nature of such radiopharmaceuticals, great care must be utilized in handling. It is common industry practice for the outside pharmacy to ship the syringe-loaded radiopharmaceutical (or other unit dose format) in a shielded container, referred to as a “radiopharmaceutical pig”. The radiopharmaceutical pig generally consists of a base and a cover that is threadably attachable to the base. For various reasons, it is important for caregivers and/or pharmacies to quickly recognize when a radiopharmaceutical pig has been opened (i.e., the cover unscrewed from the base). One current approach for providing this tamper evident safety feature is by applying a shrink wrap about the radiopharmaceutical pig. To effectuate disassembly of the cover from the base, the shrink wrap must be removed (or at least torn). While viable, this approach entails added manufacturing/handling costs, and caregivers may experience difficulties in removing and/or disposing of the shrink wrap.
- Aspects of the present disclosure relate to a tamper evident seal and method for sealing a radiopharmaceutical container. The seal includes a first band, a second band and a connector assembly adapted to be positioned around the container. First and second arms connect the first band to the second band. The connector assembly includes a connector connecting two ends of the seal together and a breakaway portion provided to separate two ends of the seal so as to provide visual evidence the seal has been broken.
- In one embodiment, the first band forms an uninterrupted circle adapted to be positioned around an upper portion of the container and the second band includes the connector assembly and is adapted to be positioned around a lower portion of the container. In a further embodiment, the first arm connects the first band to a first leg of the connector assembly and the second arm connects the first band to a second leg of the connector assembly.
- The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
-
FIG. 1 is a perspective view of an assembly including a safety seal partially assembled to a radiopharmaceutical container. -
FIG. 2 is a perspective view of the safety seal ofFIG. 1 . - In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
- It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
-
FIG. 1 illustrates an assembly including a harness orsafety seal 10 partially assembled to a radiopharmaceutical container orpig 12. As a point of reference, theradiopharmaceutical pig 12 generally includes (upon final assembly) atube 14 from which aflange 16 radially projects. Thetube 14 includes upper andlower portions flange 16 consisting of threadably securedhalves tube portions - As further illustrated in
FIG. 2 , theharness 10 is formed of a flexible, strong material, such as low density polyethylene (LDPE), and defines a first band orring 20,arms connector assembly 24. Other types of plastic can also be used, such as polypropylene, high density polyethylene (HDPE), etc. In the embodiment illustrated, thefirst band 20 is a continuous, uninterrupted circle (or similar shape) having a diameter greater than that of thetube 14, but less than that of theflange 16. Thearms first band 20 with theconnector assembly 24. Theconnector assembly 24 includesopposing legs connection tab 28.Leg 26 a extends between first andsecond ends leg 26 b extends between first andsecond ends 30 b, 32 b. Although illustrated wherein the second band forms theconnector assembly 24, the connector assembly can be formed in one or more of the other portions ofseal 10. For example, the connector assembly can be formed infirst band 20,arms - As initially provided, the
first ends 30 a, 30 b are interconnected by theconnection tab 28. Thefirst end 30 a is connected to a first portion of thetab 28 and spaced apart from the first end 30 b. The second ends 32 a, 32 b are free. In other words, thesecond ends legs first leg 26 a forms amale plug 34, and thesecond leg 26 b forms afemale receptacle 36 at the corresponding second end 32. Theplug 34/receptacle 36 are configured such that theplug 34 can be captured within thereceptacle 36, and such that once captured, theplug 34 cannot be removed from thereceptacle 36 without destroying the plug 34 (i.e., forming a non-removable connector). - During use, the
seal 10 is applied over theradiopharmaceutical pig 12 by sliding theconnector assembly 24 and thefirst band 20 over thetube 14. Due to the extendable nature of thelegs second ends legs flange 16. Thefirst band 20, however, has a diameter less than that of theflange 16, and thus cannot slide beyond theflange 16. Once in the partial assembled position as shown inFIG. 1 , thesecond ends plug 34 to be inserted within, and thus by captured by, thereceptacle 36. To this end, twogrips second ends plug 34 intoreceptacle 36. In this secured state, an effective diameter of theconnector assembly 24 is now less than that of theflange 16. Thus, theharness 10 is “locked” about theflange 16. In this position, thepharmaceutical pig 12 cannot be disassembled (i.e., theflange halves - To access
pig 12, theseal 10 must first be removed; this is accomplished by breaking the connection tab 28 (e.g., theconnection tab 28 is twisted relative to thelegs legs flange 16. As a result, the user can now slide theseal 10 off of thepharmaceutical pig 12. The removedseal 10 will clearly have the “broken” connection tab 28 (e.g., theconnection tab 28 will no longer be connected to one or both of thelegs second ends - Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
Claims (15)
Priority Applications (1)
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US12/357,017 US8512306B2 (en) | 2009-01-21 | 2009-01-21 | Radiopharmaceutical unit dose container tamper evident safety seal |
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US12/357,017 US8512306B2 (en) | 2009-01-21 | 2009-01-21 | Radiopharmaceutical unit dose container tamper evident safety seal |
Publications (2)
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US20100185170A1 true US20100185170A1 (en) | 2010-07-22 |
US8512306B2 US8512306B2 (en) | 2013-08-20 |
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US12/357,017 Active 2030-10-26 US8512306B2 (en) | 2009-01-21 | 2009-01-21 | Radiopharmaceutical unit dose container tamper evident safety seal |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100135497A1 (en) * | 2008-12-01 | 2010-06-03 | Sudhakar Gosukonda Naga Venkat Satya | Communication with non-repudiation |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3253673A4 (en) * | 2015-02-04 | 2018-08-08 | Killara I.P. Pty Ltd | Tamper evident security lid for a medical container |
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